Bone cement mixing cartridge and method of use

ABSTRACT

A container for bone cement includes a first member defining a chamber, which contains a first ingredient. The chamber also includes a second member movably coupled to the first member. The second member includes a mixing device that is movably disposed within the first chamber, and the second member defines a second chamber containing a second ingredient. The container additional includes an opening device that selectively opens the second chamber and allows the second ingredient to enter from the second chamber into the first chamber. The mixing device is movable within the first chamber to promote mixing of the first ingredient and the second ingredient to prepare the bone cement. A corresponding method of preparing bone cement is also disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 15/985,462, filed May 21, 2018, which is acontinuation of U.S. patent application Ser. No. 15/193,391, filed Jun.27, 2016, now U.S. Pat. No. 9,974,589, which is a continuation of U.S.patent application Ser. No. 14/201,105, filed Mar. 7, 2014, now U.S.Pat. No. 9,492,947, which is a continuation of U.S. patent applicationSer. No. 13/912,789, filed Jun. 7, 2013, now U.S. Pat. No. 8,668,37,which is a divisional of U.S. patent application Ser. No. 12/196,394,filed Aug. 22, 2008, now U.S. Pat. No. 8,480,289. The disclosures of allof the above-referenced prior applications, publications, and patentsare incorporated by reference herein in their entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The present disclosure relates to a mixing cartridge and, moreparticularly, relates to a bone cement mixing cartridge and method ofuse.

The statements in this section merely provide background informationrelated to the present disclosure and may not constitute prior art.

Bone cement is commonly used for bonding implants and prosthetics tobone and for other purposes. Bone cements are often made by mixingmultiple ingredients, such as a liquid monomer and a polymeric powder,typically under a vacuum. Once the ingredients are mixed and the bonecement achieves the desired viscosity, the bone cement is delivered tothe desired surface (e.g., the bone). Various bone cement mixing anddelivery implements have been proposed for facilitating this process.

Although these conventional implements have been adequate for intendeduses, they suffer from certain disadvantages. For instance, somecontainers allow harmful vapors to escape. Furthermore, it can bedifficult to ensure proper proportions of the ingredients have beenadded to the container, and an improper ratio of ingredients cancompromise the properties of the bone cement. Additionally, theseimplements can include a relatively large number of separate components,making them somewhat awkward to use. For instance, ingredients manuallydecanted from pouches or other containers can cause spills resulting ina messy and potentially dangerous waste of ingredients.

SUMMARY OF THE INVENTION

A container for bone cement is disclosed that includes a first memberdefining a chamber that is operable to contain a first ingredient. Thechamber also includes a second member movably coupled to the firstmember. The second member includes a mixing device that is movablydisposed within the first chamber, and the second member defines asecond chamber that is operable to contain a second ingredient. Thecontainer additionally includes an opening device that is operable toselectively open the second chamber and allow the second ingredient toenter from the second chamber into the first chamber. The mixing deviceis movable within the first chamber to promote mixing of the firstingredient and the second ingredient to prepare the bone cement.

In another aspect, a container is disclosed for bone cement. Thecontainer includes a first member including a tube with an open firstend and an open second end. The first member also includes a capcovering the first end and a piston movably disposed within the tubeadjacent the second end. The tube, the cap, and the piston cooperate todefine a first chamber. The container further includes a pre-measuredfirst ingredient disposed within the first chamber and a port defined inthe cap that enables coupling the first chamber to a vacuum source.Additionally, the container includes a second member movably coupled tothe first member. The second member includes a rod, a mixing disccoupled to a first end of the rod, and a handle member that is coupledto a second end of the rod. The second member additionally includes asealing member. The mixing disc is movably disposed in the firstchamber, and the rod movably extends through the cap. The handle memberis disposed outside the first chamber, and the first end of the rodincludes an aperture that is sealed by the sealing member. The rod andthe sealing member cooperate to define at least a portion of a secondchamber. The container further includes a pre-measured second ingredientdisposed within the second chamber. Also, the container includes apiercing member disposed in the first chamber. The piercing memberselectively pierces the sealing member to allow the second ingredient toenter from the second chamber into the first chamber. The handle memberis movable relative to the first member to move the mixing disc withinthe first chamber to promote mixing of the first ingredient and thesecond ingredient to prepare the bone cement.

A method of producing bone cement in a container is also disclosed. Thecontainer includes a first member that defines a first chamber, a secondmember movably coupled to the first member, and an opening device. Thesecond member includes a mixing device movably disposed within the firstchamber. The method includes moving the second member of the containerrelative to the first member to move the mixing device in the firstchamber. The method also includes selectively opening a second chamberdefined in the second member with the opening device to cause a secondingredient in the second chamber to enter the first chamber. Also, themethod includes mixing the second ingredient with a first ingredient inthe first chamber by moving the mixing device in the first chamber.

Further areas of applicability will become apparent from the descriptionprovided herein. It should be understood that the description andspecific examples are intended for purposes of illustration only and arenot intended to limit the scope of the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings described herein are for illustration purposes only and arenot intended to limit the scope of the present disclosure in any way.

FIG. 1 is a perspective view of a bone cement container according toteachings of the present disclosure;

FIG. 2 is a side view of the bone cement container of FIG. 1 in aninitial stage of preparing the bone cement;

FIG. 3 is a side view of the bone cement container of FIG. 1 in anintermediate stage of preparing the bone cement;

FIG. 4 is a side view of the bone cement container of FIG. 1 in a latterstage of preparing the bone cement;

FIG. 5 is a side view of another embodiment of the bone cement containeraccording to the teachings of the present disclosure; and

FIG. 6 is a side view of another embodiment of the bone cement containeraccording to the teachings of the present disclosure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The following description is merely exemplary in nature and is notintended to limit the present disclosure, application, or uses. Itshould be understood that throughout the drawings, correspondingreference numerals indicate like or corresponding parts and features.

Initially referring to FIG. 1, a container 10 for bone cement isillustrated. It will be appreciated that the container 10 can includeone or more features disclosed in U.S. Pat. No. 4,721,390, filed Oct.17, 1985, U.S. Pat. No. 5,328,262, filed Feb. 3, 1993, U.S. Pat. No.5,501,520, filed Apr. 26, 1994, U.S. Patent Publication No.2006/0109737, filed Apr. 29, 2005, and/or U.S. Patent Publication No.2007/0016215, filed Aug. 2, 2005, each of which is incorporated byreference in its entirety.

Generally, the container 10 includes a first member 12 which defines afirst chamber 14. A first ingredient 16 for the preparation of bonecement is contained within the first chamber 14. The container furtherincludes a second member 18, which is movably coupled to the firstmember 12. The second member 18 defines a second chamber 20. A secondingredient 22 for the preparation of bone cement is contained within thesecond chamber 20. Furthermore, the container 10 includes an openingdevice 24 that selectively opens the second chamber 20 and allows thesecond ingredient 22 to enter from the second chamber 20 into the firstchamber 14. When the first and second ingredients 16, 22 are mixed, bonecement is formed in the first chamber 14. This bone cement can then bedispensed from the first chamber 14 onto any suitable surface (e.g.,bone, etc.).

In some embodiments, the first ingredient 16 is a polymeric powder andthe second ingredient 22 is a liquid monomer. It will be appreciatedthat the first and second ingredients 16, 22 can be of any suitabletype. For instance, in some embodiments, the first ingredient 16 isceramic powder. Furthermore, in some embodiments, the second ingredient22 is an aqueous setting solution. It will also be appreciated that thefirst ingredient 16 can be contained within the second chamber 20 whilethe second ingredient 22 can be contained within the first chamber 12.

Furthermore, in some embodiments, the first and second ingredients 16,22 are pre-measured and provided in the first and second chambers 14,20, respectively. As such, the container 10 can be packaged and sold soas to be ready for use to make bone cement. Thus, the container 10provides a convenient and accurate means for making bone cement.

As shown in FIGS. 1-3, the first member 12 can include a tube 26. Insome embodiments, the tube 26 is cylindrical so as to define a linearaxis X. The tube 26 includes a first open end 28 and a second open end30 at opposite axial ends of the tube 26. In some embodiments, the firstopen end 28 is threaded on its outer surface.

The first member 12 can also include a cap 32, which is disposed on andsubstantially covers the first end 28 of the tube 26. In someembodiments, the cap 32 includes threading on an interior surface forthreadably coupling to the first end 28 of the tube 26.

Moreover, the first member 12 can include a piston 36. The piston 36 ismovably disposed within the tube 26 to change a volume of the firstchamber 14 as will be described in greater below. In an initial state ofthe container 10 represented in FIG. 1 (i.e., before the first andsecond ingredients 16, 22 are mixed), the piston 36 is disposed adjacentthe second end 30 of the tube 26. The piston 36 moves along the axis Xtoward the first end 28 once the bone cement is produced as will bedescribed in greater detail below.

The container 10 can also include a port 38. In some embodiments, theport 38 is defined in the cap 32. Also, in some embodiments, the port 38is threaded on an outer surface. As will be described, the port 38enables coupling the first chamber 14 to a vacuum source 40 (FIGS. 2 and3). Furthermore, in some embodiments, the container 10 includes adispensing tube 42 that removably couples to the port 38 and enablesdispensing of the bone cement from the first chamber 14 (FIG. 4).

In some embodiments, the second member 18 is moveable along the axis Xrelative to the first member 12 to promote mixing of the first andsecond ingredients 16, 22. Accordingly, in some embodiments, the secondmember 12 includes a mixing device 44. The mixing device 44 can be flatand disc-shaped with a plurality of legs 46 that extend transverselyfrom the axis X. The legs 46 are disposed in spaced relationshiprelative to each other so as to define a space 48 between each of thelegs 46. Furthermore, each leg 46 includes an enlarged head 50 at aterminal end thereof. The mixing device 44 is movably disposed in thefirst chamber 14. More specifically, in some embodiments, the mixingdevice 44 is moveable along the axis X toward the first and second ends,28, 30 of the tube 26. Also, in some embodiments, the legs 46 are longenough to substantially span the width of the tube 26.

The second member 18 can also include an extension member 52. In someembodiments, the extension member 52 is elongate and rod-shaped. Theextension member 52 includes a first end 54 and a second end 56 that isfixedly coupled to the mixing device 44. The extension member 52 movablyextends through a central aperture 58 in the cap 32 so as to besubstantially aligned with the axis X. As such, the first end 54 of theextension member 52 extends out of the first chamber 14.

The extension member 52 defines a passage 60 therein. The passage 60partially defines the second chamber 20. Furthermore, the extensionmember 52 includes an aperture 62 (FIGS. 2 and 3) at the second end 56of the extension member 52. As will be described in greater detail, thesecond ingredient 22 flows from the second chamber 20 into the firstchamber 14 through the aperture 62.

The second member 18 can also include a handle member 64. In someembodiments, the handle member 64 is disc-shaped and is centered aboutthe axis X. The handle member 64 is fixedly coupled to the first end 54of the extension member 52. As such, the handle member 64 is disposedoutside the first chamber 14 of the container 10.

In some embodiments, the handle member 64 is substantially hollow so asto define a handle chamber 66 therein. The handle chamber 66 partiallydefines the second chamber 20. The handle chamber 66 is in communication(e.g., fluid communication) with the passage 60 of the extension member52. As will be described, the handle member 64 and the extension member52 are moveable relative to the first member 12 to move the mixingdevice 44 within the first chamber 14 to promote mixing of the firstingredient and the second ingredient, 16, 22 and to prepare the bonecement.

Furthermore, the second member 18 can include a sealing member 68 (FIGS.2 and 3). In some embodiments, the sealing member 68 is a thin membranethat seals the aperture 62 of the extension member 52. It will beappreciated that the sealing member can be made of any suitablematerial, such as aluminum foil coated with polyethylene.

Thus, the handle chamber 64 and the passage 60 collectively define thesecond chamber 20. In other words, the handle member 64, the extensionmember 52, and the sealing member 68 cooperate to define the volume ofthe second chamber 20. Likewise, the tube 26, the cap 32, and the piston36 cooperate to define the volume of the first chamber 14. It will beappreciated that the first ingredient 16 remains independent of thesecond ingredient 22 until the sealing member 68 unseals the aperture 62of the extension member 52.

Additionally, the opening device 24 can include a base 70 and a piercingmember 72. In some embodiments, the base 70 is disc-shaped, and thepiercing member 72 comes to a sharpened point. The opening device 24 isdisposed within the first chamber 14 between the piston 36 and themixing device 44. In some embodiments, the opening device 24 issupported on the piston 36 such that the sharpened point of the piercingmember 72 faces the sealing member 68. Furthermore, in some embodiments,the passage 60, the sealing member 68, and the piercing member 72 aresubstantially aligned along the axis X. Moreover, in some embodiments,the width of the base 70 is substantially less than the width of thefirst chamber 14. As will be described, the opening device 24selectively opens the second chamber 20 by piercing the sealing member68, thereby selectively unsealing the aperture 62 of the extensionmember 52.

Moreover, the container 10 can also include a guard member 74 (FIG. 1).Generally, the guard member 74 selectively limits movement of the handlemember 64, the extension member 52, and the mixing device 44 toward theopening device 24. As such, the guard member 74 reduces the likelihoodof inadvertent piercing of the sealing member 68 by the piercing member72 of the opening device 24. In some embodiments, the guard member 74includes a relatively thin, flexible strip of material or membrane thatis wrapped around the container 10 and disposed between the handlemember 64 and the cap 32. In other embodiments, the guard member 74includes one or more removable rods that extend between the handlemember 64 and the cap 32. Furthermore, in some embodiments, the guardmember 74 is removably coupled to the handle member 64 and/or the cap32. The guard member 74 can be integral, molded, glued, snap-fit, weldedor otherwise removably coupled to the handle member 64 and the cap 32.Additionally, in some embodiments, the guard member 74 seals the spacebetween the handle member 64 and the cap 32 such that the port 38 issubstantially sealed from contamination. Also, the guard member 74 canbe disposed anywhere on the container 10, including inside the firstchamber 14.

Thus, in order to make and produce bone cement using the prepackagedcontainer 10 represented in FIG. 1, the guard member 74 is first removedfrom the handle member 64 and the cap 32. This exposes the port 38 andallows movement of the second member 18 relative to the first member 12.

Then, the vacuum source 40 is operatively coupled to the first chamber14 via the port 38. In some embodiments, a filter device 80 is disposedadjacent the first end 28 and at least partially over the port 38 forinhibiting bone cement and/or the first or second ingredients 16, 22from being sucked into the vacuum source 40.

Next, the user grasps the handle member 64 and pushes the handle member64 downward along the axis X such that the mixing device 44 and thesealing member 68 move toward the piercing member 72 (FIG. 2).Eventually, the piercing member 72 pierces through the sealing member 68and unseals the aperture 62. Because of the vacuum provided by thevacuum source 40, the second ingredient 22 flows from the handle chamber66 and the passage 60 through the aperture 62 and into the first chamber14 to mix with the first ingredient 16. In some embodiments, once thesealing member 68 is pierced, the second ingredient 22 flows out ofsmall openings pierced in the sealing member 68, and these openings aresufficiently small to inhibit backflow from the first chamber 14 to thepassage 60. Also, in some embodiments, the piercing member 72substantially plugs the aperture 62 once the second ingredient 22 flowsout into the first chamber 14 to inhibit backflow from the first chamber14 into the passage 60. In still further embodiments, the passage 60includes a one way valve that allows the second ingredient 22 to flowinto the first chamber 14 but that inhibits backflow from the firstchamber 14 into the passage 60.

Once the second ingredient 22 begins flowing into the first chamber 14,the user can agitate the mixture of the first and second ingredients 16,22 by grasping the handle member 64 and moving the mixing device 44 upand down along the axis X and/or rotating the mixing device 44 about theaxis X. The legs 46 and the heads 50 of the mixing device 44 facilitatemixing of the first and second ingredients 16, 22. In some embodiments,once the first and second ingredients 16, 22 are mixed, a reactionoccurs to form the bone cement 90 (FIG. 4).

Once the first and second ingredients 16, 22 are sufficiently mixed(e.g., into a homogeneous mixture) the user grasps the handle member 64and moves the handle member 64, the extension member 52, and the mixingdevice 44 upward along the axis X toward the first end 28 of the tube26. In some embodiments, the opening device 24 is detachably supportedby the piston 36 such that the opening device 24 remains frictionallyattached to the second member 18 once the piercing member 72 pierces thesealing member 68, and movement of the second member 18 toward the firstend 28 of the tube 26 pulls the opening device 24 toward the first end28 of the tube 26 (FIG. 4).

Continued operation of the vacuum source 40 draws the piston 36 upwardalong the axis X toward the first end 28 of the tube 26 and also drawsout air bubbles within the bone cement 90. It will be appreciated thatthis movement of the piston 36 substantially eliminates open spacebetween the piston 36 and the cap 32 and substantially gathers the bonecement 90 therebetween. In some embodiments, the piston 36 movesselectively away from the second end 30. For instance, the piston 36 andthe tube 26 can include corresponding locking tabs. The locking tabsretain the piston 36 in position adjacent the second end 30. Then, whenthe user so chooses, the piston 36 can turn the piston 36 about the axisX to unlock the corresponding locking tabs and allow the piston 36 tomove toward the first end 28 of the tube 26.

Then, once the vacuum 40 is removed, the extension member 52 can bebroken just above the cap 32, and the filter device 80 can be removedfrom the port 38. Subsequently, the dispensing tube 42 can be threadedto the port 38, and the container 10 can be loaded into a dispensingdevice, such as a bone cementing gun (not specifically shown) fordispensing the bone cement 90 to the intended area. It will beappreciated that the opening device 24 substantially seals the passage60 such that the bone cement 90 is unlikely to flow out of the firstchamber 14 through the passage 60. It will also be appreciated that thewidth of the base 70 is such that the bone cement 90 is able to bypassthe base 70 and flow out of the first chamber 14 through the port 38.

Referring now to FIG. 5, a container 110 is illustrated according tovarious other embodiments of the present disclosure. Features that aresimilar to those of the container 10 of FIGS. 1-4 are identified withsimilar reference numerals increased by 100.

As shown in FIG. 5, the container 110 includes an opening device 124wherein the piercing member 172 remains attached to the piston 136. Asshown, the piercing member 172 has a length sufficient enough to extendfrom the piston 136 and into the aperture 162 to substantially plug theaperture 162. For example, the length of the piercing member 172 isapproximately two centimeters in some embodiments. Because the piercingmember 172 substantially plugs the aperture 162, the bone cement 190 isunlikely to backflow into the passage 160. Also, the bone cement 190 isless likely to be contaminated.

Referring now to FIG. 6, a container 210 is illustrated according tovarious other embodiments of the present disclosure. Features that aresimilar to those of the container 10 of FIG. 1-4 are identified withsimilar reference numerals increased by 200.

As shown in FIG. 6, the container 210 includes a first member 212 and asecond member 218. The second member 218 includes a handle member 264and an extension member 252. The second chamber 220 is definedsubstantially within only the extension member 252. It will beappreciated that the extension member 252 can be of any suitable width,diameter, length, or other dimension so as to encapsulate apredetermined amount of the second ingredient 222.

By depressing the handle member 264 and moving the extension member 252toward the opening device 224, the piercing member 272 pierces thesealing member 268. This unseals the aperture 262 in the extensionmember 252, thereby allowing the second ingredient 222 to flow out fromthe second chamber 220 and into the first chamber 214 to mix with thefirst ingredient 216. It will be appreciated that the container 210 canbe simpler to manufacture because the second chamber 220 is definedsubstantially within only the extension member 252.

In summary, the container 10 allows for convenient manufacture of bonecement 90 because the first and second ingredients 16, 22 can bepremeasured and disposed within the first and second chambers 14, 20,respectively and because mixing the ingredients 16, 22 can be performedwith relatively few steps. Also, the first and second ingredients 16, 22can be mixed substantially without exposing the user to harmful vaporsbecause the mixing can be performed under vacuum. Moreover, thesterility of the ingredients 16, 22 and ultimately the bone cement 90can be ensured using the container 10. Furthermore, the container 10 isrelatively compact for additional convenience.

Moreover, the foregoing discussion discloses and describes merelyexemplary embodiments of the present disclosure. One skilled in the artwill readily recognize from such discussion, and from the accompanyingdrawings and claims, that various changes, modifications and variationsmay be made therein without departing from the spirit and scope of thedisclosure as defined in the following claims.

1-20. (canceled)
 21. A method of producing bone cement in a container,the method comprising: moving a second member of the container relativeto a first member of the container to move a mixing device coupled to anelongated extension member of the second member within a first chamberof the first member, the elongated extension member having an inletpassage therein, the inlet passage partially defining a second chamberof the second member; opening the inlet passage of the elongated memberby opening a sealing member covering an opening of the inlet passage atthe end of the elongated extension member with an opening devicepositioned within the first chamber to allow a second ingredient in thesecond chamber to enter the first chamber through the inlet passage; andmixing the second ingredient with a first ingredient in the firstchamber by moving the second member to move the mixing device in thefirst chamber.
 22. The method of claim 21, further comprising dispensingthe bone cement through an outlet port.
 23. The method of claim 22,wherein the outlet port is separate from the inlet passage.
 24. Themethod of claim 21, further comprising generating a vacuum in the firstchamber.
 25. The method of claim 21, further comprising coupling thefirst chamber to a vacuum source.
 26. The method of claim 25, furthercomprising applying a vacuum to an outlet port in communication with thefirst chamber to provide suction to the first chamber to move the secondingredient from the second chamber into the first chamber.
 27. Themethod of claim 21, wherein opening the inlet passage comprises piercingthe sealing member with the opening device.
 28. The method of claim 27,wherein the opening device includes a piercing member that selectivelypierces the sealing member.
 29. The method of claim 28, the methodfurther comprising plugging the inlet passage with the piercing memberto inhibit backflow from the first chamber into the inlet passage. 30.The method of claim 28, wherein the piercing member is approximately 2cm in length.
 31. The method of claim 21, wherein the second memberfurther includes a handle defining a handle chamber, the handle chamberin communication with the inlet passage and defining a portion of thesecond chamber.
 32. The method of claim 21, wherein the first ingredientcomprises a ceramic powder.
 33. The method of claim 32, wherein thesecond ingredient comprises an aqueous setting solution.
 34. A method ofdispensing bone cement, the method comprising: moving a second member ofa container relative to a first member of the container to move a mixingdevice coupled to an extension member of the second member within afirst chamber of the first member, the extension member having thereinan inlet passage at least partially defining a second chamber; couplingthe first chamber to a vacuum source; opening a sealing member, coveringan opening of the inlet passage at the end of the extension member, withan opening device positioned within the first chamber to allow a secondingredient in the second chamber to enter the first chamber through theinlet passage; mixing the second ingredient with a first ingredient inthe first chamber to form bone cement by moving the second member tomove the mixing device in the first chamber; coupling a dispensing tubeto an outlet port in communication with the first chamber; anddispensing said bone cement through the dispensing tube via the outletport.
 35. The method of claim 34, further comprising applying a vacuumto the first chamber to provide suction to the first chamber to move thesecond ingredient from the second chamber into the first chamber. 36.The method of claim 35, wherein coupling the first chamber to a vacuumsource comprises coupling the vacuum source to an outlet port incommunication with the first chamber.
 37. The method of claim 36,wherein the outlet port is attached to the first member.
 38. The methodof claim 34, wherein opening the sealing member comprises piercing thesealing member.
 39. The method of claim 34, wherein opening the sealingmember comprises piercing the sealing member with an opening devicepositioned in the first chamber.
 40. The method of claim 34, the methodfurther comprising plugging the inlet passage with the piercing memberto inhibit backflow from the first chamber into the inlet passage.